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临床试验/NCT05843539
NCT05843539已完成不适用

Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

University of Lorraine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Quality of life of women in remission from breast cancer

研究概览

简要总结

Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase.

ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications.

The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Have had breast cancer
  • Be considered in remission
  • Be over 18 years of age
  • Literate (able to understand the information and complete the questionnaire independently)
  • Agree to participate in the project and sign the informed consent form

排除标准

  • Be a person subject to a legal protection measure
  • Be a protected adult, under guardianship or curators
  • Be undergoing oncological treatment
  • Have a lack of autonomy making it impossible to complete the questionnaire online
  • Have had or have begun psychotherapeutic treatment

结局指标

主要结局

Quality of life of women in remission from breast cancer

时间窗: Baseline. Through study completion, an average of 1 year.

The primary outcome was quality of life assessed with the Short Form Survey 12 (SF-12 scale). The score ranges from 0 to 100, with a score above 50 indicating average quality of life, 40 to 49 indicating mild disability, 30 to 39 indicating moderate disability, and below 30 indicating severe disability.

次要结局

  • Attachment(Baseline. Through study completion, an average of 1 year.)
  • Anxiety and Depression(Baseline. Through study completion, an average of 1 year.)
  • Fear of recurrence(Baseline. Through study completion, an average of 1 year.)
  • Fatigue(Baseline. Through study completion, an average of 1 year.)
  • Adverse Childhood Experiences(Baseline. Through study completion, an average of 1 year.)
  • Resilience(Baseline. Through study completion, an average of 1 year.)
  • RMSSD values(Baseline. Through study completion, an average of 1 year.)

研究者

发起方
University of Lorraine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Rotonda

Director of the research pole in Pierre Janet Center

University of Lorraine

研究点 (1)

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